Cleared Traditional

K232749 - DOOPANG (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232749 · Ybrain, Inc. · Neurology device
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Jun 2024
Decision
277d
Days
Class 2
Risk

K232749 is an FDA 510(k) clearance for the DOOPANG. Classified as Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC), Class II - Special Controls.

Submitted by Ybrain, Inc. (Daejeon, KR). The FDA issued a Cleared decision on June 11, 2024 after a review of 277 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5891 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ybrain, Inc. devices

Submission Details

510(k) Number K232749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2023
Decision Date June 11, 2024
Days to Decision 277 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 148d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5891
Definition Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Gms Consulting
Jonghyun Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

All 17
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